510(k) · Cleared
ClearedLight Scalpel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lightscalpel, LLC · GEX Powered Laser Surgical Instrument
Cleared on Oct 22, 2014 as substantially equivalent to K123037 (Lightscalpel, LLC, 2012) and 4 other predicates after a 124-day review. Its family tree reaches back 9 generations to 1994. 2 later devices descend from it.
- Decided
- Oct 22, 2014
- Review
- 124 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K936109 (1994). 71 ancestors in all, the oldest K822136 (1982). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 5 generations between
- 3 generations backK040234 Laserpro CO2 Carbon Dioxide Laser SystemPhoto Medex, Inc. · 2004
- 2 generations backK080463 Alma Lasers Thermoxel CO2 Laser System and Delivery Device AccessoriesAlma Lasers, Ltd. · 2008
- 1 generation backK103501 Alma Lasers Pixel CO2 Laser System, Delivery Device and AccessoriesAlma Lasers, Inc. · 2011
- This deviceK141658 Light ScalpelLightscalpel, LLC · 2014
- Descendant · cites it directly · 0 of its ownK213669 Lightscalpel LS-4020Lightscalpel, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK173827 LightScalpelLightscalpel, LLC · 2018
Show all 9 generations
- Root · 9 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 8 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 7 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 6 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 5 generations backK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
- 4 generations backK030147 Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003
- 3 generations backK040234 Laserpro CO2 Carbon Dioxide Laser SystemPhoto Medex, Inc. · 2004
- 2 generations backK080463 Alma Lasers Thermoxel CO2 Laser System and Delivery Device AccessoriesAlma Lasers, Ltd. · 2008
- 1 generation backK103501 Alma Lasers Pixel CO2 Laser System, Delivery Device and AccessoriesAlma Lasers, Inc. · 2011
- This deviceK141658 Light ScalpelLightscalpel, LLC · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −8 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −6 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −5 | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device… | Lumenis, Inc. | 2002 | — |
| −4 | K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers | Lumenis, Ltd. | 2003 | — |
| −3 | K040234 | Laserpro CO2 Carbon Dioxide Laser System | Photo Medex, Inc. | 2004 | — |
| −2 | K080463 | Alma Lasers Thermoxel CO2 Laser System and Delivery Device Accessories | Alma Lasers, Ltd. | 2008 | — |
| −1 | K103501 | Alma Lasers Pixel CO2 Laser System, Delivery Device and Accessories | Alma Lasers, Inc. | 2011 | — |
| 0 (this device) | K141658 | Light Scalpel | Lightscalpel, LLC | 2014 | — |
| +1 | K213669 | Lightscalpel LS-4020 | Lightscalpel, Inc. | 2023 | — |
| +1 | K173827 | LightScalpel | Lightscalpel, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 7 | 0 |
| 1996 | 6 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123037 | LightscalpelSummary page 9…ted by carbon dioxide.” Classification: Class II Product Code: GEX 4. Predicate Device(s): 4.1. LightScalpel LS-1005 CO2 Laser System; K123037 & K132661 4.2. Alma Pixel CO2™ Laser System; K103501 4.3. Lumenis AcuPulse™ 30/40 ST & 40WG CO2 Laser Systems; K100415 4… | 2012 |
| * | K132661 | LightscalpelSummary page 9…bon dioxide.” Classification: Class II Product Code: GEX 4. Predicate Device(s): 4.1. LightScalpel LS-1005 CO2 Laser System; K123037 & K132661 4.2. Alma Pixel CO2™ Laser System; K103501 4.3. Lumenis AcuPulse™ 30/40 ST & 40WG CO2 Laser Systems; K100415 4.4. Sharpl… | 2014 |
| * | K103501 | Alma Lasers Pixel CO2 Laser System, Delivery Device and AccessoriesSummary page 9…fication: Class II Product Code: GEX 4. Predicate Device(s): 4.1. LightScalpel LS-1005 CO2 Laser System; K123037 & K132661 4.2. Alma Pixel CO2™ Laser System; K103501 4.3. Lumenis AcuPulse™ 30/40 ST & 40WG CO2 Laser Systems; K100415 4.4. Sharplan 15F CO2 Laser System; K971743 001_Sum2… | 2011 |
| * | K100415 | Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemSummary page 9…4.1. LightScalpel LS-1005 CO2 Laser System; K123037 & K132661 4.2. Alma Pixel CO2™ Laser System; K103501 4.3. Lumenis AcuPulse™ 30/40 ST & 40WG CO2 Laser Systems; K100415 4.4. Sharplan 15F CO2 Laser System; K971743 001_Sum2 VOL_006-001 P… | 2010 |
| * | K971743 | Sharplan CO2 Surgical Laser SystemSummary page 9…23037 & K132661 4.2. Alma Pixel CO2™ Laser System; K103501 4.3. Lumenis AcuPulse™ 30/40 ST & 40WG CO2 Laser Systems; K100415 4.4. Sharplan 15F CO2 Laser System; K971743 001_Sum2 VOL_006-001 Page 1 of 7… | 1997 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 71 ancestors has a recall of any class.
- Of its descendants, K213669 (Lightscalpel, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K123037.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The LightScalpel LS-1005 & LS-2010 CO2 Laser Systems are intended for use in laser surgery procedures for incision, excision, vaporization, ablation, and/or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, orthopedic surgery, neurosurgery, podiatry, and urology. Gynecology / Genitourinary: Incision, excision, ablation, and/or…
Read the full statement (824 words)
The LightScalpel LS-1005 & LS-2010 CO2 Laser Systems are intended for use in laser surgery procedures for incision, excision, vaporization, ablation, and/or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, orthopedic surgery, neurosurgery, podiatry, and urology.
Gynecology / Genitourinary:
Incision, excision, ablation, and/or vaporization of soft tissue for treatment of: Conization of the cervix, including cervical intraepithelial neoplasia and vulvar and vaginal intraepithelial neoplasia; Condyloma, including cervical, genital, vulvar, perineal, and Bowenoid papulosa; leukoplakia (vulvar dystrophies); incision and drainage of Bartholin’s and nabothian cysts; herpes vaporization; urethral caruncle vaporization; cervical dysplasia; benign and malignant tumors; hemangiomas; benign and malignant lesions of external genitalia; condyloma; phimosis; erythroplasia.
Dermatology / Plastic Surgery:
Incision, Excision, Ablation, and Vaporization of soft tissue for performance of or treatment of: laser skin resurfacing; laser dermabrasion; laser burn debridement; wrinkles, rhytids, and furrows; keratosis, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheci wart, and verruca seborrheica; vermillionectomy of the lip; cutaneous horns; solar/actinic elastosis; cheilitis, including actinic cheilitis; lentigines, including lentigo maligna or Hutchinson’s malignant freckle; uneven pigmentation/dyschromia; acne scars; surgical scars; keloids, including acne keloidalis nuchae; hemangiomas, including Buccal, port wine, and pyogenic granulomas/granuloma, pyogenicum/granuloma telagiectaticum; tattoos; telangiectasias; removal of small skin tumors, including periungual (Koenen) and subungual fibromas; superficial pigmented lesions; adenosebaceous hypertrophy or sebaceous hyperplasia; rhinophyma reduction; cutaneous papilloma (skin tags); milia; debridement of eczematous or infected skin; basal & squamous cell carcinoma, including keratoacanthomas, Bowen’s disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions; nevi, including spider, epidermal, and protruding; neurofibromas; laser de-epithelialization; tricoepitheliomas; xanthelasma palpebrarum; syringoma; complete or partial nail matrixectomy; benign/malignant vascular/avascular skin lesions; Mohs surgery; lipectomy; verrucae and seborrhoecae vulgares, including: paronychial, periungal, and subungual warts; blepharoplasty; and hair transplantation site preparation.
Dental Surgery:
Gingivectomy — Removal of hyperplasias; gingivoplasty; papillectomy; vestibuloplasty; epulis; sulcular debridement; removal of soft tissue, cysts, and fibroma (non-malignant tumor, mucosa, tongue); extraction site hemostasis; treatment of ulcerous lesions, including aphthous ulcers; a heat source to activate tooth bleaching materials; Laser Assisted New Attachment Procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium).
Oral Surgery:
Frenum release/frenectomy; abscess (drainage); flap surgery; biopsy (incisional & excisional); aphthous ulcers (incision & excision); excision & ablation of lesions, benign & malignant lesions, oral cavity tumors, and hemangiomas; salivary gland pathologies; preprosthetic gum preparation, leukoplakia; partial glossectomy; periodontal gum resection; homeostasis; operculectomy; crown lengthening (soft tissue); incision of infection when used with antibiotic therapy; extraction site hemostasis.
General and Thoracic Surgery:
Incision, excision, and vaporization of soft tissue in general and thoracic surgery, including endoscopic and open procedures for: debridement of decubitus ulcers, stasis, diabetic, and other ulcers; mastectomy; debridement of burns; rectal and anal hemorrhoidectomy; breast biopsy, reduction mammoplasty; cytoreduction for metastatic disease, laparotomy and laparoscopic applications; mediastinal and thoracic lesions and abnormalities; skin tag vaporization; atheroma; cysts, including sebaceous and pilar cysts, and mucous cysts of the lips; pilonidal cyst removal and repair; abscesses; other soft tissue applications.
Gyn Laparoscopic Surgery:
Laser incision, excision, vaporization, and photocoagulation of soft tissue for treatment of: endometrial lesions, including ablation for endometriosis; excision/lysis of adhesions; salpingotomy; oophorectomy/ovariectomy; fimbrioplasty; metroplasty; uterine myomas and fibroids; ovarian fibromas and follicle cysts; uterosacral ligament ablation;
hysterectomy.
Otorhinolaryngology / ENT:
Laser incision, excision, ablation, vaporization, and / or photocoagulation of soft tissue in otorhinolaryngology for treatment of: leukoplakia, including oral, larynx, uvula, palatal, and upper lateral pharyngeal tissue; adult and juvenile papillomatosis polyps; lymphangioma removal; removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx, and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue, and vocal cords; stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis and neoplasma) and tonsil ablation / tonsillotomy; benign and malignant tumors and fibromas (oral); superficial lesions of the ear, including chondrodermatitis nondularis chronica helices / Winkler’s disease; uvulopalatoplasty (LAUP, laser UPPP); turbinectomy and turbinate reduction / ablation; septal spur ablation/reduction and septoplasty; partial glossectomy; tumor resection of oral, subfacial, and neck tissues; rthinophyma; verrucae vulgares (warts); gingivoplasty / gingivectomy
Podiatry:
Laser excision, ablation, and /or vaporization of soft tissue in podiatry for the reduction, removal and/or treatment of: Verrucae vulgares / plantar warts, including paronychial, periungual, and subungual warts; fungal nail treatment; matrixectomy — partial and complete; porokeratoma ablation; neuromas/fibromas, including Morton’s neuroma removal; ingrown toenail treatment; debridement of ulcers; treatment of other soft tissue lesions.
Orthopedic Surgery:
Laser incision / excision, ablation, and /or vaporization of soft tissue in orthopedic surgery. Applications include: meniscectomy; chondromalacia ablation; chondroplasty; ligament release (lateral and other); excision of plica; partial synovectomy; debridement of traumatic wounds; debridement of decubitus & diabetic ulcers; and PMMA removal.
Neurosurgery:
Laser incision / excision, ablation, and /or vaporization of soft tissue in neurosurgery for the treatment of: posterior fossa tumors; peripheral neurectomy; benign and malignant tumors and cysts (e.g. gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas, and large tumors); arteriovenous malformation; and pituitary gland tumors (transphenoidal approach).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141658: Light Scalpel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141658
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026